(300 days)
The intended use of the Tecno reusable bipolar electrosurgical forceps is to grasp and coagulate (control bleeding) by use of high-frequency electrical current. The forceps can be used multiple (come of have been AAMI performance tested after 20 exposures to steam sterilization. The areas of specialty that the Tecno electrosurgical bipolar forceps will be used is: neurosurgical, opthalmic, plastic and reconstructive surgical procedures.
Indications for use are hemorrhaging of compromised tissue and subsequent need to coagulate during invasive surgical procedures.
REUSABLE BIPOLAR ELECTROSURGICAL FORCEPS
This 510(k) clearance letter from the FDA for "Reusable Bipolar Electrosurgical Forceps" does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving the device meets those criteria.
The letter primarily confirms that the device is substantially equivalent to a predicate device and allows it to be marketed. It refers to "AAMI performance tested after 20 exposures to steam sterilization" but provides no specifics on the acceptance criteria, the performance metrics, or the study details.
Here's a breakdown of what can and cannot be answered based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The document only briefly mentions "AAMI performance tested after 20 exposures to steam sterilization." This implies there were performance criteria related to the device's functionality after repeated sterilization cycles, but the specific metrics (e.g., coagulation effectiveness, insulation integrity, mechanical strength) and their acceptance thresholds are not provided. | Not specified in this document. While it states the device was "AAMI performance tested," the actual performance results or a comparison against specific criteria are not included in this letter. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. The document is a regulatory clearance, not a study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a surgical instrument, not an diagnostic imaging or AI device requiring expert-established ground truth for its performance evaluation in the context of this regulatory letter. Its performance would likely be evaluated against engineering specifications and functional tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device and the information provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a surgical instrument, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated. For a reusable surgical instrument, "ground truth" for performance would typically involve:
- Engineering specifications/Standards: Compliance with AAMI standards for electrosurgical devices and sterilization.
- Functional testing: E.g., ability to grasp, effectively coagulate, maintain insulation integrity, and withstand sterilization cycles without degradation.
- Biocompatibility: Assuring materials are safe for patient contact.
- The document only alludes to "AAMI performance tested after 20 exposures to steam sterilization," suggesting compliance with applicable standards.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael T. Janocik President Rightworks, Inc. PO Box 991251 Louisville, Kentucky 40269
AUG 1 4 1997
Re: K964176
Trade Name: Reusable Bipolar Electrosurgical Forceps Regulatory Class: II Product Code: GEI Dated: June 18, 1997 Received: June 20, 1997
Dear Mr. Janocik:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Michael T. Janocik
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K964176
Device Name: REUSABLE BIPOLAR ELECTROSURGICAL FORCEPS
Indications For Use:
The intended use of the Tecno reusable bipolar electrosurgical forceps is to grasp and coagulate (control bleeding) by use of high-frequency electrical current. The forceps can be used multiple (come of have been AAMI performance tested after 20 exposures to steam sterilization. The areas of specialty that the Tecno electrosurgical bipolar forceps will be used is: neurosurgical, opthalmic, plastic and reconstructive surgical procedures.
Indications for use are hemorrhaging of compromised tissue and subsequent need to coagulate during invasive surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K964176 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.